Effect of Pancreatic Polypeptide on Intragastric Pressure and Satiety During Nutrient Drink Infusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The effect of different doses of pancreatic polypeptide infusion on the gastric accommodation (intragastric pressure drop) after nutrient drink infusion.
研究概览
简要总结
The investigators want to observe whether different doses of pancreatic polypeptide infusions influence gastric accommodation (measured as intragastric pressure changes during a liquid meal infusion), gastric emptying and food intake.
详细描述
As pancreatic polypeptide (PP) influences food behavior in humans, our research group suggests a role via the the gastric accommodation or gastric emptying. Twelve healthy volunteers participated in this single blind, placebo-controlled, crossover trial. An infusion catheter and a manometry probe were positioned in the stomach. After a 15 min stabilization period, saline (placebo), PP 3 pmol/kg*min or PP 10 pmol/kg*min were intravenously infused. Thirty min after the condition, an intragastric nutrient drink (ND) infusion (60 ml/min) started until the volunteer felt maximal satiated. GE was evaluated using the 13C breath test during the 6 hours following the ND infusion. Satiation and hunger were scored on a visual analog scale every 5 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is between 18 and 65 years of age.
- •Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- •Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •Subject is under age of legal consent, pregnant or breastfeeding.
- •Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
- •Subject has a significant heart, lung, liver or kidney disease.
- •Subject has any history of a neurological disorder. Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
- •History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
- •History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
- •Subject consumes excessive amounts of alcohol, defined as >14 units per week for females and > 21 units per week for males.
- •Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
- •High caffeine intake (> 500 ml coffee daily or equivalent).
- •Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
- •Recent participation (<30 days) or simultaneous participation in another clinical study.
- •Subjects with lactose intolerance.
研究组 & 干预措施
3 pmol/kg*min pancreatic polypeptide
3 pmol/kg*min of pancreatic polypeptide was intravenously infused.
干预措施: 3 pmol/kg*min pancreatic polypeptide (Drug)
10 pmol/kg*min pancreatic polypeptide
10 pmol/kg*min of pancreatic polypeptide was intravenously infused.
干预措施: 10 pmol/kg*min pancreatic polypeptide (Drug)
Placebo
0.9 % saline solution was intravenously infused.
干预措施: Placebo (Drug)
结局指标
主要结局
The effect of different doses of pancreatic polypeptide infusion on the gastric accommodation (intragastric pressure drop) after nutrient drink infusion.
时间窗: Until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after pancreatic peptide dose or placebo iv infusion.
Intragastric pressure measurements were assessed using a 36-channel high-resolution solid-state manometry probe. After nutrient drink infusion, the intragastric pressure drops to a minimum value (Nadir), which is a measurement for gastric accommodation, and the pressure restores after. The time point of reaching the Nadir is different between subjects, but pressure is measured until 2 hours after nutrient drink to assess the drop.
次要结局
- The effect of different doses of pancreatic polypeptide infusion on nutrient tolerance.(Infusion of the liquid meal ends after 20 minutes or earlier if max satiation is reached by the subjects.)
- The effect of different doses of pancreatic polypeptide infusion on gastric emptying rate.(Breath samples were collected in exetainers, twice before and every 15 min after the meal until 6 hours thereafter.)
- The effect of different doses of pancreatic polypeptide infusion on satiety and return of hunger.(Satiety and hunger were scored twice before and every 15 min after the meal until 6 hours thereafter.)